Design and methods for the training in exercise activities and motion for growth (TEAM 4 growth) trial: A randomized...

Area of Science:

• Pediatric Cardiology
• Neonatal Development
• Clinical Trials

Background:

• Infants with congenital heart disease often experience impaired growth, linked to developmental issues and longer hospital stays.
• While various interventions exist, their success in enhancing growth varies.
• Passive range of motion (PROM) has shown promise in improving somatic growth in preterm infants.

Purpose of the Study:

• To evaluate the efficacy of a 21-day passive range of motion (PROM) exercise program on growth in infants with hypoplastic left heart syndrome (HLHS) post-Norwood procedure.
• To compare growth metrics (weight-, height-, head circumference-for-age z-scores) at 4 months of age or pre-superior cavopulmonary connection evaluation.
• To assess secondary outcomes including neonatal neurobehavior, neurodevelopment, and bone mineral density.

Main Methods:

• A multicenter, Phase III randomized controlled trial comparing PROM exercise to standard care.
• Inclusion criteria: HLHS diagnosis, born at ≥37 weeks gestation, Norwood procedure <30 days old.
• Exclusion criteria: chromosomal abnormalities, transplant listing, or expected discharge within 14 days.

Main Results:

• Data on growth metrics (z-scores) will be collected and compared between groups.
• Secondary outcomes including neurobehavioral patterns, neurodevelopmental assessment, and bone mineral density will be analyzed.
• The study aims to provide robust data on the impact of PROM on these outcomes.

Conclusions:

• The TEAM 4 Growth trial will contribute significantly to understanding PROM's role in growth for infants with complex cardiac anomalies.
• Findings may inform interventions for high-risk infants facing growth failure and developmental concerns.
• This research could enhance long-term outcomes for infants with HLHS.